Diabetic RetinopathyAssessNCT05566717
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
An observational study of Diabetic Retinopathy and Neurotrophic Keratitis, run by Medical Center Ophthalmology Associates at 1 site in United States.
Trial summary
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Neurotrophic Keratitis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: This is a single-center, controlled study to assess the association of diabetic retinopathy severity with reduction in corneal sensitivity in approximately 50 Type 1 and Type 2 diabetes subjects (100 eyes) at least 18 years of age and meeting all other study eligibility criteria.
Who may be able to join
- Have Type 1 or Type 2 diabetes with DRSS of 3 or higher
- Be willing and able to sign the informed consent form (ICF)
- Be at least 18 years of age
- Be literate and able to complete questionnaires independently
- Have provided verbal and written informed consent
Who cannot join
- Have a history of vitrectomy
- Have a history of cornea, eyelid, glaucoma, or retina surgery
- Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia
- Have a history of ocular herpes simplex virus infection
- Have a history of herpes zoster ophthalmicus
- Have a history of ocular chemical trauma
Show all 12Show fewer
- Have a history of underlying corneal dystrophies
- Have had cataract surgery less than 3 months prior
- Have a history of pan-retinal photocoagulation (PRP)
- Have current Stage 2 or 3 neurotrophic keratopathy
- Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Lolita Kirschbaum, 210-697-2020, lkirschbaum@mcoaeyecare.com
msinger@mcoaeyecare.com
About this study
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
Read the detailed description
This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.
- Conditions
- Diabetic Retinopathy, Neurotrophic Keratitis
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
- To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Jul 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Ophthalmology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Oyster Point Pharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566717
- Sponsor's protocol ID
- ASSESS
- Acronym
- Assess
- Status last verified
- Sep 2022
- First submitted
- 2 Aug 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared however demographics and baseline characteristics will be summarized.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
- ClinicalTrials.gov ID
- NCT05566717
- Acronym / sponsor ID
- Assess / ASSESS
- Conditions
- Diabetic Retinopathy, Neurotrophic Keratitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical Center Ophthalmology AssociatesUniversity, hospital or other
- Collaborators
- Oyster Point Pharma, Inc.
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
Detailed description
This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a single-center, controlled study to assess the association of diabetic retinopathy severity with reduction in corneal sensitivity in approximately 50 Type 1 and Type 2 diabetes subjects (100 eyes) at least 18 years of age and meeting all other study eligibility criteria.
Key inclusion criteria (5 listed)
- Have Type 1 or Type 2 diabetes with DRSS of 3 or higher
- Be willing and able to sign the informed consent form (ICF)
- Be at least 18 years of age
- Be literate and able to complete questionnaires independently
- Have provided verbal and written informed consent
Key exclusion criteria (12 listed)
- Have a history of vitrectomy
- Have a history of cornea, eyelid, glaucoma, or retina surgery
- Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia
- Have a history of ocular herpes simplex virus infection
- Have a history of herpes zoster ophthalmicus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Endpoint
Time frame: 3months
• To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No. IPD will not be shared however demographics and baseline characteristics will be summarized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Neurotrophic Keratitis, run by Medical Center Ophthalmology Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lolita Kirschbaum (2106972006, lkirschbaum@mcoaeyecare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.